Identity
- Trade Name
- TeraRecon Aorta.CT EUDAMED
- Device Name
- TeraRecon Aorta.CT EUDAMED
- Model / Reference
- 1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B220AORTACT0 EUDAMED
- Basic UDI-DI
- ++B220AORTACTQP EUDAMED
- Direct Marketing DI
- +B220AORTACT0 EUDAMED
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
TeraRecon Aorta.CT by Terarecon Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B220AORTACTQP | Class IIa | Active |
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Manufacturer
- Manufacturer
- TeraRecon, Inc.
- EUDAMED SRN
- US-MF-000008772
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED ca78f284-6dd1-4d4d-8b5f-7d3ebb77a491 61 fields · synced May 23, 2026